Definition: To Fragment Metallic Clips And Remove Them From The Digestive Tract.
| Device Type ID | 2168 |
| Device Name | Endoscopic Electrosurgical Clip Cutting System |
| Physical State | Generator Supplies Energy To Clip Cutter, Whose Tip Is Placed On The Opposite Edges Of The Metallic Clip, And Direct Current Is Applied To Fragment The Clip. |
| Technical Method | Applies Direct Current Across Clip Edges. |
| Target Area | Gastrointestinal Tract, Digestive Tract. |
| Regulation Description | Endoscopic Electrosurgical Clip Cutting System. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.4310 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QAG |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2168 |
| Device | Endoscopic Electrosurgical Clip Cutting System |
| Product Code | QAG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscopic Electrosurgical Clip Cutting System. |
| CFR Regulation Number | 876.4310 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
OVESCO ENDOSCOPY | ||
GRANTED | 1 | |